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Compensation: Varies

Number of Visits: 2

30 Participants Needed

PASAT for Fibromyalgia

Overseen ByMelyssa Godfrey, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Chronic disease, Vision loss, Epilepsy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Fibromyalgia (FM) is a chronic musculoskeletal pain disorder with unknown causes. Our previous studies showed abnormal sensations of second pain (wind-up), indicating central hypersensitivity as an important mechanism of FM. Triggering events have been implicated as the cause of central hypersensitivity.

Do I need to stop my current medications for the trial?

Yes, if you are a fibromyalgia patient, you must stop taking your fibromyalgia-related medications for at least one day before the visit.

How is the PASAT treatment different from other treatments for fibromyalgia?

The PASAT treatment is unique because it focuses on improving cognitive functions like working memory and attention, which are often impaired in fibromyalgia patients. Unlike typical pain management treatments, PASAT targets the brain's ability to process information and manage tasks, potentially addressing cognitive deficits associated with the condition.¹ ² ³ ⁴ ⁵

Research Team

Roland Staud, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for individuals diagnosed with Fibromyalgia (FM) who have experienced pain for more than 3 months and meet specific diagnostic criteria. Healthy people without chronic pain can also join as controls. Participants should not have chronic diseases or significant vision loss, and FM patients must pause their medications for at least a day before the visit.

Inclusion Criteria

I am healthy, without chronic pain, and match the age and sex criteria.

I have been diagnosed with fibromyalgia and have had pain for more than 3 months.

Exclusion Criteria

I am willing to stop my fibromyalgia medication for at least one day before my visit.

I have a long-term illness like cancer or diabetes.

Significant vision loss not corrected by eye wear

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Baseline evaluation of light and pain sensitivity using QST examinations and VEP

1-2 weeks

1 visit (in-person)

Experimental Task

Participants undergo the PASAT task to assess sensory testing responses

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after experimental tasks

4 weeks

Treatment Details

Interventions

Paced Auditory Serial Addition task (PASAT)

Trial OverviewThe study is testing how people with FM respond to a Paced Auditory Serial Addition Task (PASAT), which may help understand central hypersensitivity—a key mechanism in FM that relates to abnormal pain perception.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Effects of PASAT on Sensory TestingExperimental Treatment1 Intervention

After baseline evaluation of light and pain sensitivity FM subjects and controls will undergo the PASAT task. This task consists of responding to a rapid presentation of numbers by ear phones. Subjects are asked to add each 2 consecutive numbers and provide a response each time the sum is equal to 13. This test will last several minutes and delivered at increasing speed.

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Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

Individuals with fibromyalgia show significant impairments in cognitive functions related to controlled processes, particularly in tasks involving working memory and executive function.

The study found that both temporal orienting (faster reaction times for attended targets) and response inhibition were notably worse in fibromyalgia patients compared to a control group, suggesting dysfunction in the frontal networks responsible for attentional control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal preparation and inhibitory deficit in fibromyalgia syndrome.Correa, A., Miró, E., Martínez, MP., et al.[2019]

Patients with fibromyalgia (FM) showed a significant increase in pain sensitivity during an experiment, indicating a long-lasting sensitization to pain despite no initial difference in pressure pain thresholds compared to healthy controls.

Electrophysiological data revealed that FM patients had altered cognitive processing of pain-related information, as evidenced by reduced P200 amplitudes and a lack of enhanced responses to unpleasant words, suggesting a different way of processing emotional pain stimuli.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered processing of pain-related information in patients with fibromyalgia.Montoya, P., Pauli, P., Batra, A., et al.[2006]

In a study involving 50 fibromyalgia patients and 60 healthy controls, the expected increased auditory processing in fibromyalgia patients was not observed; instead, they showed reduced auditory event-related potentials (AEPs) to loud sounds.

Medication with central effects was found to significantly reduce AEPs in fibromyalgia patients, suggesting that while sensory amplification may not be evident, it could still play a role in the condition's underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intensity, attention and medication on auditory-evoked potentials in patients with fibromyalgia.Samartin-Veiga, N., González-Villar, AJ., Triñanes, Y., et al.[2021]